510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K782137Substantially Equivalent

Medtronic Model 3797 Electrode

Medtronic, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K782137 is the FDA 510(k) clearance record for MEDTRONIC MODEL 3797 ELECTRODE, a class II device, cleared for Medtronic Vascular on under FDA product code GXY (Electrode, Cutaneous). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K782137.

Clearance record

Decision date
Received
(42 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Medtronic Vascular 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GXY

Trailing 12 months
11 clearances under product code GXY in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code GXY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20262
May 20263
June 20262
July 20261
August 20261
September 20260
October 20260